Back to resultsAnti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
Primary Purpose
Dyspepsia, Chronic Gastritis
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Rebamipide
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring Patients suffering of dyspepsia due to chronic gastritis
Eligibility Criteria
Inclusion Criteria:
Patients who
- are 18 - 80 years old
- have symptoms of dyspepsia that need endoscopic examination
- are suffering from chronic moderate to severe gastritis which is confirmed endoscopically
- are able to give informed concern
Exclusion Criteria:
Patients who
- are treated with drugs that induce gastritis/ulcer, such as: NSAID
- are chronic alcoholism,
- are drug abuser
- are contraindicated for endoscopy examination
- has erosive or ulcerative esophagitis
- has peptic ulcer that has been confirmed by endoscopy
- has pyloric stenosis
- has active gastrointestinal bleeding
- has major absorption disorder
- has history of gastric surgery
- with renal disorder (creatinine > 2 mg/dL)
- with liver disease ( SGOT, SGPT, bilirubin)
- have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count)
- are suffering from congestive gastropathy due cirrhosis
- are suffering from congestive heart disease
- are pregnant or giving breast feeding
- are hypersensitive to Rebamipide
- are treated with gastroprotective drugs such as : teprenone, sucralfate.
- are treated with acid suppressing medicine (H2A, PPI)
- are treated with antibiotics, mesalazine (Salofalk)
Sites / Locations
- Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rebamipide
Arm Description
Rebamipide 100 mg tid for 28 days
Outcomes
Primary Outcome Measures
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation
Secondary Outcome Measures
To confirm the improvement of dyspepsia syndrome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00996788
Brief Title
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
Official Title
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Otsuka Indonesia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the anti free radical & inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Chronic Gastritis
Keywords
Patients suffering of dyspepsia due to chronic gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rebamipide
Arm Type
Experimental
Arm Description
Rebamipide 100 mg tid for 28 days
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Intervention Description
Rebamipide 100 mg tid for 28 days
Primary Outcome Measure Information:
Title
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation
Time Frame
2 times (at day-0 and day-28)
Secondary Outcome Measure Information:
Title
To confirm the improvement of dyspepsia syndrome
Time Frame
3 times (at day-0, day-7 and day-28)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who
are 18 - 80 years old
have symptoms of dyspepsia that need endoscopic examination
are suffering from chronic moderate to severe gastritis which is confirmed endoscopically
are able to give informed concern
Exclusion Criteria:
Patients who
are treated with drugs that induce gastritis/ulcer, such as: NSAID
are chronic alcoholism,
are drug abuser
are contraindicated for endoscopy examination
has erosive or ulcerative esophagitis
has peptic ulcer that has been confirmed by endoscopy
has pyloric stenosis
has active gastrointestinal bleeding
has major absorption disorder
has history of gastric surgery
with renal disorder (creatinine > 2 mg/dL)
with liver disease ( SGOT, SGPT, bilirubin)
have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count)
are suffering from congestive gastropathy due cirrhosis
are suffering from congestive heart disease
are pregnant or giving breast feeding
are hypersensitive to Rebamipide
are treated with gastroprotective drugs such as : teprenone, sucralfate.
are treated with acid suppressing medicine (H2A, PPI)
are treated with antibiotics, mesalazine (Salofalk)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aziz Rani, MD
Organizational Affiliation
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
City
Jakarta
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
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